Strategy & Trends with Forecasts by Assay Type, by Place, by Product, by Manufacturer and by Country. Situation Analysis with Executive & Consultant Guides. 2024 to 2028
Howe Sound Research Published June 2024 – 367 pages
The IVD Quality Control industry rose to the challenge of the pandemic. Now new opportunities abound in this established industry that is immune from recession. New technology and new segments are driving runaway growth. Understand the opportunities and the threats in this comprehensive report.
The fundamentals are still here. Clinical laboratory testing is positioned to directly benefit from the explosion in biotechnology, especially genomics. A range of dynamic trends are pushing market growth and company valuations. The Quality Control industry stands to gain.
The report provides data that analysts and planners can use. Hundreds of pages of information including detailed information on clinical laboratory trends and the role of IVD. Forecast demand for new testing regimes or technologies.
The report includes detailed breakouts for 15 Countries and 4 Regions. A detailed breakout for any country in the world is available to purchasers of the report.
All report data is available in Excel format on request.
Make investment decisions and valuations with confidence using the latest data.
Your report is provided on a 12-month subscription basis from the date you receive your first report. You will receive 2 or more updated versions of the complete report during the 12 months. At least one of these updates will provide forecasts based on next year’s data.
1 Market Guides …………………………………………………………………………………………………… 17
1.1 Strategic Situation Analysis …………………………………………………………………………………. 18
1.2 Guide for Executives, Marketing, Sales and Business Development Staff ………………. 21
1.3 Guide for Management Consultants and Investment Advisors …………………………….. 22
2 Introduction and Market Definition …………………………………………………………………….. 23
2.1 What is IVD Quality Control? ………………………………………………………………………………. 24
2.2 Defining the Opportunity ……………………………………………………………………………………. 26
2.2.1 Revenue Market Size ………………………………………………………………………………………. 26
2.3 Methodology …………………………………………………………………………………………………….. 28
2.3.1 Methodology …………………………………………………………………………………………………. 28
2.3.2 Sources ………………………………………………………………………………………………………….. 28
2.3.3 Authors ………………………………………………………………………………………………………….. 28
2.4 Perspective: Healthcare and the IVD Industry …………………………………………………….. 30
2.4.1 Global Healthcare Spending ………………………………………………………………………….. 30
2.4.2 Spending on Diagnostics ………………………………………………………………………………… 32
2.4.3 Important Role of Insurance for Diagnostics …………………………………………………….. 33
3 Overview of a Dynamic Market ………………………………………………………………………….. 34
3.1 Players in a Dynamic Market ………………………………………………………………………………. 35
3.1.1 Academic Research Lab ……………………………………………………………………………….. 36
3.1.2 Diagnostic Test Developer ………………………………………………………………………………. 36
3.1.3 Instrumentation Supplier …………………………………………………………………………………. 37
3.1.4 Chemical/Reagent Supplier ……………………………………………………………………………. 37
3.1.5 Pathology Supplier …………………………………………………………………………………………. 37
3.1.6 Independent Clinical Laboratory ……………………………………………………………………. 37
3.1.7 Public National/regional Laboratory ……………………………………………………………….. 38
3.1.8 Hospital Laboratory ………………………………………………………………………………………… 38
3.1.9 Physicians Office Lab (POLS) …………………………………………………………………………… 39
3.1.10 Audit Body ………………………………………………………………………………………………….. 39
3.1.11 Certification Body ……………………………………………………………………………………….. 39
3.2 Segmentation – Different Approaches ……………………………………………………………….. 41
3.2.1 Traditional Market Segmentation…………………………………………………………………….. 41
3.2.2 Laboratory Focus and Segmentation ………………………………………………………………. 43
3.3 Structure of Clinical Testing Industry ……………………………………………………………………. 45
3.3.1 The Hospital Lab – Share of the Pie ………………………………………………………………….. 45
3.3.2 Key Role for Economies of Scale ……………………………………………………………………… 45
3.3.3 Physician Office Lab’s are Still Here …………………………………………………………………. 47
3.3.4 Physician’s and POCT – Reviving Patient Service in China ………………………………… 48
3.4 National and Regional Diversity ………………………………………………………………………….. 49
4 Trends Driving a Changing Market ……………………………………………………………………… 51
4.1 Growth Is Pushed from Many Sides ……………………………………………………………………… 52
4.1.1 Demographic Impacts on Consumption …………………………………………………………. 53
4.1.2 Alternative Suppliers ……………………………………………………………………………………….. 55
4.1.3 Impact of POC ………………………………………………………………………………………………. 55
4.1.4 Impact of Accreditation …………………………………………………………………………………. 56
4.1.5 Genetic and Molecular Issues …………………………………………………………………………. 56
4.2 Factors at Work to Shrink the Market …………………………………………………………………… 57
4.2.1 Where are Costs Going? ………………………………………………………………………………… 58
4.2.2 Management Practices ………………………………………………………………………………….. 58
4.2.3 Cannabilization ……………………………………………………………………………………………… 58
4.2.4 Point of Care ………………………………………………………………………………………………….. 58
4.3 Automation and Laboratory Trends ……………………………………………………………………. 59
4.3.1 Traditional Automation and Centralization ………………………………………………………. 59
4.3.2 The New Automation, Decentralization and Point Of Care ………………………………. 59
4.3.3 Instruments Key to Market Share ……………………………………………………………………… 61
4.3.4 Bioinformatics Plays a Role ……………………………………………………………………………… 61
4.3.5 PCR Takes Command …………………………………………………………………………………….. 61
4.3.6 Next Generation Sequencing Fuels a Revolution ……………………………………………… 63
4.3.7 NGS Impact on Pricing ……………………………………………………………………………………. 64
4.3.8 Whole Genome Sequencing, A Brave New World …………………………………………… 64
4.3.9 Companion Diagnostics Blurs Diagnosis and Treatment …………………………………… 64
4.3.10 Shifting Role of Diagnostics ………………………………………………………………………….. 65
5 IVD Quality Control Recent Developments …………………………………………………………. 67
5.1 Recent Developments – Importance and How to Use This Section ………………………. 68
5.1.1 Importance of These Developments ……………………………………………………………….. 68
5.1.2 How to Use This Section …………………………………………………………………………………… 68
5.2 New FDA Quality Regulations Spark Questions ……………………………………………………. 68
5.3 Waters MassTrak Steroid Serum (IVD) Sets ……………………………………………………………. 74
5.4 Cancer Test Harmonization Efforts Progress …………………………………………………………. 74
5.5 Bio-Techne Expanding With Ella Immunoassay Instrument ……………………………………. 78
5.6 ZeptoMetrix QC Products Receive IVDR Certification ………………………………………….. 80
5.7 Coverage Criteria for Cancer Genetic Tests Creates Alarm ………………………………… 81
5.8 IVDR Rollout Brings QC Hurdles for Clinical Labs …………………………………………………… 87
5.9 LGC Clinical Diagnostics Acquires QC Product Maker Kova International ……………. 95
5.10 FDA Probing Lab Test Quality in Cancer Care ……………………………………………………… 96
5.11 Sensible Diagnostics to Launch 10-Minute POC PCR System ………………………………. 104
5.12 Streck Gets FDA Clearance for BioFire Sepsis Panel Control Material ………………….. 107
6 Profiles of Key Companies ………………………………………………………………………………… 109
6.1 Abbott Laboratories …………………………………………………………………………………………. 110
6.2 Alpha-Tec Systems …………………………………………………………………………………………… 112
6.3 Beckman Coulter Diagnostics (Danaher) ………………………………………………………….. 113
6.4 Becton, Dickinson and Company …………………………………………………………………….. 114
6.5 BioFire Diagnostics (bioMérieux) ……………………………………………………………………….. 116
6.6 bioMérieux Diagnostics …………………………………………………………………………………….. 118
6.7 Bio-Rad Laboratories, Inc………………………………………………………………………………….. 121
6.8 Bio-Techne ………………………………………………………………………………………………………. 122
6.9 Danaher Corporation ………………………………………………………………………………………. 123
6.10 Diasorin S.p.A. ………………………………………………………………………………………………….. 125
6.11 Fortress Diagnostics ………………………………………………………………………………………….. 126
6.12 Grifols ………………………………………………………………………………………………………………. 127
6.13 Helena Laboratories …………………………………………………………………………………………. 129
6.14 Hologic ……………………………………………………………………………………………………………. 130
6.15 LGC Standards ………………………………………………………………………………………………… 132
6.16 Maine Molecular Quality Controls …………………………………………………………………….. 133
6.17 Microbiologics …………………………………………………………………………………………………. 135
6.18 Microbix Systems ……………………………………………………………………………………………… 136
6.19 Novacyt ………………………………………………………………………………………………………….. 137
6.20 QuidelOrtho …………………………………………………………………………………………………….. 138
6.21 Randox Toxicology …………………………………………………………………………………………… 140
6.22 Seegene………………………………………………………………………………………………………….. 141
6.23 SERO ……………………………………………………………………………………………………………….. 142
6.24 Siemens Healthineers ……………………………………………………………………………………….. 143
6.25 Streck ………………………………………………………………………………………………………………. 144
6.26 Sun Diagnostics ……………………………………………………………………………………………….. 145
6.27 Sysmex …………………………………………………………………………………………………………….. 146
6.28 Thermo Fisher Scientific …………………………………………………………………………………….. 148
6.29 ZeptoMetrix ……………………………………………………………………………………………………… 150
7 The Global Market for IVD Quality Control ………………………………………………………… 151
7.1 Global Market Overview by Country ………………………………………………………………… 152
7.1.1 Table – Global Market by Country …………………………………………………………………. 152
7.1.2 Chart – Global Market by Country …………………………………………………………………. 153
7.2 Global Market by Assay Type – Overview ………………………………………………………….. 154
7.2.1 Table – Global Market by Assay Type …………………………………………………………….. 154
7.2.2 Chart – Global Market by Assay Type – Base/Final Year Comparison………………. 155
7.2.3 Chart – Global Market by Assay Type – Base Year ………………………………………….. 156
7.2.4 Chart – Global Market by Assay Type – End Year …………………………………………… 157
7.2.5 Chart – Global Market by Assay Type – Share by Year ……………………………………. 158
7.2.6 Chart – Global Market by Assay Type – Segments Growth ……………………………… 159
7.3 Global Market by Place – Overview ………………………………………………………………….. 160
7.3.1 Table – Global Market by Place …………………………………………………………………….. 160
7.3.2 Chart – Global Market by Place – Base/Final Year Comparison ……………………… 161
7.3.3 Chart – Global Market by Place – Base Year………………………………………………….. 162
7.3.4 Chart – Global Market by Place – End Year …………………………………………………… 163
7.3.5 Chart – Global Market by Place – Share by Year ……………………………………………. 164
7.3.6 Chart – Global Market by Place – Segments Growth ……………………………………… 165
7.4 Global Market by Product – Overview ………………………………………………………………. 166
7.4.1 Table – Global Market by Product …………………………………………………………………. 166
7.4.2 Chart – Global Market by Product – Base/Final Year Comparison …………………… 167
7.4.3 Chart – Global Market by Product – Base Year ………………………………………………. 168
7.4.4 Chart – Global Market by Product – End Year ……………………………………………….. 169
7.4.5 Chart – Global Market by Product – Share by Year ………………………………………… 170
7.4.6 Chart – Global Market by Product – Segments Growth ………………………………….. 171
7.5 Global Market by Manufacturer- Overview ………………………………………………………. 172
7.5.1 Table – Global Market by Manufacturer ………………………………………………………… 172
7.5.2 Chart – Global Market by Manufacturer – Base/Final Year Comparison ………….. 173
7.5.3 Chart – Global Market by Manufacturer – Base Year ……………………………………… 174
7.5.4 Chart – Global Market by Manufacturer – End Year ………………………………………. 175
7.5.5 Chart – Global Market by Manufacturer – Share by Year ……………………………….. 176
7.5.6 Chart – Global Market by Manufacturer – Segments Growth …………………………. 177
8 Global IVD Quality Control Markets – By Assay Type ………………………………………….. 178
8.1 Chemistry ………………………………………………………………………………………………………… 179
8.1.1 Table Chemistry – by Country ……………………………………………………………………….. 179
8.1.2 Chart – Chemistry Growth ……………………………………………………………………………… 180
8.2 Microbiology ……………………………………………………………………………………………………. 181
8.2.1 Table Microbiology – by Country …………………………………………………………………… 181
8.2.2 Chart – Microbiology Growth ………………………………………………………………………… 182
8.3 Hematology …………………………………………………………………………………………………….. 183
8.3.1 Table Hematology – by Country ……………………………………………………………………. 183
8.3.2 Chart – Hematology Growth …………………………………………………………………………. 184
8.4 Anatomic Pathology ………………………………………………………………………………………… 185
8.4.1 Table Anatomic Pathology – by Country ……………………………………………………….. 185
8.4.2 Chart – Anatomic Pathology Growth …………………………………………………………….. 186
8.5 Molecular Diagnostics ……………………………………………………………………………………… 187
8.5.1 Table Molecular Diagnostics – by Country ……………………………………………………… 187
8.5.2 Chart – Molecular Diagnostics Growth …………………………………………………………… 188
8.6 Esoteric ……………………………………………………………………………………………………………. 189
8.6.1 Table Esoteric – by Country …………………………………………………………………………… 189
8.6.2 Chart – Esoteric Growth…………………………………………………………………………………. 190
9 Global IVD Quality Control Markets – By Place ………………………………………………….. 191
9.1 Hospital …………………………………………………………………………………………………………… 192
9.1.1 Table Hospital – by Country …………………………………………………………………………… 192
9.1.2 Chart – Hospital Growth ………………………………………………………………………………… 193
9.2 Outpatient Laboratory ……………………………………………………………………………………… 194
9.2.1 Table Outpatient Laboratory – by Country …………………………………………………….. 194
9.2.2 Chart – Outpatient Laboratory Growth ………………………………………………………….. 195
9.3 Research Laboratory ……………………………………………………………………………………….. 196
9.3.1 Table Research Laboratory – by Country ……………………………………………………….. 196
9.3.2 Chart – Research Laboratory Growth …………………………………………………………….. 197
9.4 Physicians Office Laboratory …………………………………………………………………………….. 198
9.4.1 Table Physicians Office Laboratory – by Country ……………………………………………. 198
9.4.2 Chart – Physicians Office Laboratory Growth …………………………………………………. 199
9.5 Other Laboratory ……………………………………………………………………………………………… 200
9.5.1 Table Other Laboratory – by Country …………………………………………………………….. 200
9.5.2 Chart – Other Laboratory Growth ………………………………………………………………….. 201
10 Global IVD Quality Control Markets – By Product ………………………………………….. 202
10.1 Whole Blood ……………………………………………………………………………………………………. 203
10.1.1 Table Whole Blood– by Country …………………………………………………………………. 203
10.1.2 Chart – Whole Blood Growth ……………………………………………………………………… 204
10.2 Plasma …………………………………………………………………………………………………………….. 205
10.2.1 Table Plasma – by Country ………………………………………………………………………… 205
10.2.2 Chart – Plasma Growth ……………………………………………………………………………… 206
10.3 Urine ……………………………………………………………………………………………………………….. 207
10.3.1 Table Urine – by Country ……………………………………………………………………………. 207
10.3.2 Chart –Urine Growth ………………………………………………………………………………….. 208
10.4 Control Material Other ……………………………………………………………………………………… 209
10.4.1 Table Control Material Other – by Country …………………………………………………. 209
10.4.2 Chart – Control Material Other Growth ………………………………………………………. 210
11 Global IVD Quality Control Markets – By Manufacturer …………………………………. 211
11.1 Original Equipment Manufacturer …………………………………………………………………….. 212
11.1.1 Table Original Equipment Manufacturer – by Country ………………………………… 212
11.1.2 Chart – Original Equipment Manufacturer Growth ……………………………………… 213
11.2 Third Party Generic …………………………………………………………………………………………… 214
11.2.1 Table Third Party Generic – by Country ………………………………………………………. 214
11.2.2 Chart – Third Party Generic Growth ……………………………………………………………. 215
11.3 Third Party Instrument Specific ………………………………………………………………………….. 216
11.3.1 Table Third Party Instrument Specific – by Country ………………………………………. 216
11.3.2 Chart – Third Party Instrument Specific Growth ……………………………………………. 217
11.4 Custom Other ………………………………………………………………………………………………….. 218
11.4.1 Table Custom Other – by Country ……………………………………………………………… 218
11.4.2 Chart – Custom Other Growth …………………………………………………………………… 219
12 Appendices ………………………………………………………………………………………………… 220
12.1 Growth of Approved IVD Test Menu …………………………………………………………………. 221
12.2 Growth of Approved Average IVD Test Fee ………………………………………………………. 222
12.3 The Most Used IVD Assays …………………………………………………………………………………. 223
12.4 The Highest Grossing Assays ……………………………………………………………………………… 228
12.5 Laboratory Fees Schedule ………………………………………………………………………………… 234
Table of Tables
Table 1 Market Players by Type ……………………………………………………………………………………….. 36
Table 2 Clinical Laboratory Departments and Segments …………………………………………………… 42
Table 3 Laboratory Management Focus – Different Approaches ………………………………………. 43
Table 4 Key Segmentation Variables Going Forward…………………………………………………………. 44
Table 5 Factors Affecting Local Clinical Testing Demand ………………………………………………….. 49
Table 6 Seven Factors Driving Growth ………………………………………………………………………………. 52
Table 7 Six Factors Limiting Growth …………………………………………………………………………………… 57
Table 8 Seven Key Diagnostic Laboratory Technology Trends ……………………………………………. 59
Table 9 – Global Market by Region …………………………………………………………………………………. 152
Table 10 Global Market by Assay Type ……………………………………………………………………………. 154
Table 11 Global Market by Place ……………………………………………………………………………………. 160
Table 12 Global Market by Product ………………………………………………………………………………… 166
Table 13 Global Market by Manufacturer ……………………………………………………………………….. 172
Table 14 Chemistry by Country ………………………………………………………………………………………. 179
Table 15 Microbiology by Country …………………………………………………………………………………. 181
Table 16 Hematology by Country …………………………………………………………………………………… 183
Table 17 Anatomic Pathology by Country ………………………………………………………………………. 185
Table 18 Molecular Diagnostics by Country …………………………………………………………………….. 187
Table 19 Esoteric by Country ………………………………………………………………………………………….. 189
Table 20 Hospital by Country ………………………………………………………………………………………….. 192
Table 21 Outpatient Laboratory by Country …………………………………………………………………… 194
Table 22 Research Laboratory by Country ………………………………………………………………………. 196
Table 23 Physicians Office Laboratory by Country …………………………………………………………… 198
Table 24 Other Laboratory by Country ……………………………………………………………………………. 200
Table 25 Whole Blood by Country …………………………………………………………………………………… 203
Table 26 Plasma by Country …………………………………………………………………………………………… 205
Table 27 Urine by Country ……………………………………………………………………………………………… 207
Table 28 Control Material Other by Country ……………………………………………………………………. 209
Table 29 Original Equipment Manufacturer by Country …………………………………………………… 212
Table 30 Third Party Generic by Country …………………………………………………………………………. 214
Table 31 Third Party Instrument Specific by Country ………………………………………………………… 216
Table 32 Custom Other by Country ………………………………………………………………………………… 218
Table 33 The Most Common Assays ……………………………………………………………………………….. 223
Table 34 Largest Revenue Assays ……………………………………………………………………………………. 228
Table 35 Clinical Lab Fee Schedule ………………………………………………………………………………… 234
Table of Figures
Figure 1 Global Healthcare Spending ………………………………………………………………………………. 31
Figure 2 The Road to Diagnostics ……………………………………………………………………………………… 35
Figure 3 The Changing Age of The World’s Population ………………………………………………………. 53
Figure 4 Health Care Consumption by Age ………………………………………………………………………. 54
Figure 5 Cancer Incidence – Age at Diagnosis …………………………………………………………………. 55
Figure 6 Centralized vs. Decentralized Laboratory Service ………………………………………………… 60
Figure 7 A Highly Multiplexed Syndromic Testing Unit …………………………………………………………. 60
Figure 8 The Real Cost to Sequence the Human Genome…………………………………………………. 63
Figure 9 The Codevelopment Process ………………………………………………………………………………. 65
Figure 10 Comparing MDx Diagnostic and Traditional Testing ……………………………………………. 66
Figure 11 Global Market Pareto Chart ……………………………………………………………………………. 153
Figure 12 Global Market by Assay Type – Base vs. Final …………………………………………………….. 155
Figure 13 Global Market by Assay Type Base Year …………………………………………………………… 156
Figure 14 Global Market by Assay Type End Year ……………………………………………………………. 157
Figure 15 Assay Type Share by Year ………………………………………………………………………………… 158
Figure 16 Assay Type Segments Growth ………………………………………………………………………….. 159
Figure 17 Global Market by Place – Base vs. Final…………………………………………………………….. 161
Figure 18 Global Market by Place Base Year …………………………………………………………………… 162
Figure 19 Global Market by Place End Year ……………………………………………………………………. 163
Figure 20 Place Share by Year ………………………………………………………………………………………… 164
Figure 21 Place Segments Growth ………………………………………………………………………………….. 165
Figure 22 Global Market by Product – Base vs. Final …………………………………………………………. 167
Figure 23 Global Market by Product Base Year ……………………………………………………………….. 168
Figure 24 Global Market by Product End Year …………………………………………………………………. 169
Figure 25 Product Share by Year …………………………………………………………………………………….. 170
Figure 26 Product Segments Growth ………………………………………………………………………………. 171
Figure 27 Global Market by Manufacturer – Base vs. Final ………………………………………………… 173
Figure 28 Global Market by Manufacturer Base Year ………………………………………………………. 174
Figure 29 Global Market by Manufacturer End Year ………………………………………………………… 175
Figure 30 Manufacturer Share by Year ……………………………………………………………………………. 176
Figure 31 Manufacturer Segments Growth ……………………………………………………………………… 177
Figure 32 Chemistry Growth ……………………………………………………………………………………………. 180
Figure 33 Microbiology Growth ………………………………………………………………………………………. 182
Figure 34 Hematology Growth ……………………………………………………………………………………….. 184
Figure 35 Anatomic Pathology Growth …………………………………………………………………………… 186
Figure 36 Molecular Diagnostics Growth …………………………………………………………………………. 188
Figure 37 Esoteric Growth ………………………………………………………………………………………………. 190
Figure 38 Hospital Growth ………………………………………………………………………………………………. 193
Figure 39 Out Patient Laboratory Growth ……………………………………………………………………….. 195
Figure 40 Research Laboratory Growth …………………………………………………………………………… 197
Figure 41 Physicians Office Laboratory Growth ……………………………………………………………….. 199
Figure 42 Other Laboratory Growth ………………………………………………………………………………… 201
Figure 43 Whole Blood Growth ……………………………………………………………………………………….. 204
Figure 44 Plasma Growth ……………………………………………………………………………………………….. 206
Figure 45 Urine Growth …………………………………………………………………………………………………… 208
Figure 46 Control Material Other Growth ………………………………………………………………………… 210
Figure 47 Original Equipment Manufacturer Growth ……………………………………………………….. 213
Figure 48 Third Party Generic Growth ……………………………………………………………………………… 215
Figure 49 Third Party Instrument Specific Growth ……………………………………………………………… 217
Figure 50 Custom Other Growth ……………………………………………………………………………………… 219
Figure 51 IVD Test Menu Growth …………………………………………………………………………………….. 221
Figure 52 IVD Test Average Fees – A Ten Year View …………………………………………………………. 222
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